Drugs / Voxelotor

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Oxbryta — 2022-02-14 europa.eu ↗
Label expansion US (FDA) OXBRYTA — 2021-12-17 fda.gov ↗
Approved US (FDA) OXBRYTA — 2019-11-25 fda.gov ↗

Trials 27

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT05981365 Apr → Oct 2023 sickle cell disease Pfizer Completed No outcome recorded
Phase 1 NCT03114540 Mar 2017 → Feb 2018 — Pfizer Completed No outcome recorded
Phase 1 NCT03051711 Dec 2016 → Dec 2017 — Global Blood Therapeutics Terminated No outcome recorded
Phase 1 NCT03161015 Nov 2016 → May 2017 impaired renal function disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02567695 Sep 2015 → Jun 2016 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02567682 Sep 2015 → May 2016 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02497924 Jun 2015 → Jul 2016 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02285088 Dec 2014 → Mar 2017 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04335721 Mar 2021 → Oct 2024 sickle cell disease University of Illinois at Chicago Terminated No outcome recorded
Phase 29 trials
Phase 2 NCT06023199 Oct 2023 → Sep 2025 sickle cell disease Inova Health Care Services Completed No outcome recorded
Phase 2 NCT05199766 Mar 2023 → Mar 2024 sickle cell disease Assistance Publique - Hôpitaux de Paris Unknown No outcome recorded
Phase 2 NCT05289570 May 2022 → Jun 2023 acute lung injury Duke University Terminated No outcome recorded Stop: Business
Phase 2 NCT05018728 Mar 2022 → Oct 2024 sickle cell disease Emory University Terminated No outcome recorded
Phase 2 NCT04247594 Jan 2020 → Jun 2021 sickle cell disease Pfizer Terminated No outcome recorded
Phase 2 NCT02989168 Nov 2016 → Oct 2017 idiopathic pulmonary fibrosis, polycythemia due to hypoxia Global Blood Therapeutics Terminated No outcome recorded
Phase 2 NCT03041909 Aug 2016 → Jun 2017 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 2 NCT02850406 Jul 2016 → Oct 2023 sickle cell disease Pfizer Terminated No outcome recorded
Phase 2 NCT02846324 Jun 2016 → Sep 2017 idiopathic pulmonary fibrosis, polycythemia due to hypoxia Global Blood Therapeutics Completed No outcome recorded
Phase 35 trials · 1 met primary · 1 missed
Phase 3 NCT05228834 Jun → Sep 2022 sickle cell disease Pfizer Terminated No outcome recorded
Phase 3 NCT05561140 May 2022 → Jun 2024 sickle cell disease, ulcer of lower limbs Pfizer Terminated Missed primary
Phase 3 NCT04218084 Nov 2020 → Jan 2024 sickle cell disease Pfizer Terminated Met primary
Phase 3 NCT04188509 Nov 2019 → Nov 2024 sickle cell disease Pfizer Terminated No outcome recorded
Phase 3 NCT03573882 Jun 2018 → Nov 2024 sickle cell disease Pfizer Terminated No outcome recorded
Phase 43 trials
Phase 4 NCT05228821 Aug 2023 sickle cell disease Pfizer Withdrawn No outcome recorded Stop: Business
Phase 4 NCT04400487 Dec 2020 → Sep 2022 sickle cell disease Pfizer Completed No outcome recorded
Phase 4 NCT04581356 Sep 2020 → Oct 2021 sickle cell disease Elizabeth Yang, MD, PhD Completed No outcome recorded
Phase not stated1 trial
— NCT04724421 — sickle cell disease Pfizer No longer available No outcome recorded
Comparator or background therapy2 trials
Phase 3 NCT03036813 Comparator Dec 2016 → Oct 2019 sickle cell disease Pfizer Completed No outcome recorded
— NCT03943615 Background — sickle cell disease Pfizer No longer available No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2024-09-25 Pfizer Regulatory Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA® (voxelotor) From Worldwide Markets pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA ® (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is approved.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as voxelotor “Voxelotor (GBT440) is a first-in-class oral therapy specifically developed to treat SCD” PMID 30655275 ↗ Jan 2019
19

NCT05228834 ↗

NCT04724421 ↗

NCT03943615 ↗

NCT05289570 ↗

NCT04188509 ↗

NCT05228821 ↗

NCT05981365 ↗

NCT04247594 ↗

NCT05018728 ↗

NCT04581356 ↗

Show 9 more sources

Known as GBT440 “Investigator hypothesis is that the treatment by Voxelotor (GBT440) will improve intra vascular hemolysis and will increase the total mass of hemoglobin with beneficial effects...” NCT05199766 ↗
9

“Voxelotor (GBT440) is a first-in-class oral therapy specifically developed to treat SCD” PMID 30655275 ↗ Jan 2019

NCT03051711 ↗

NCT02497924 ↗

NCT02567695 ↗

NCT03114540 ↗

NCT02846324 ↗

NCT02567682 ↗

NCT02989168 ↗

NCT03161015 ↗

Known as GTX-011 ChEMBL registry synonym — accepted as the source's own label CHEMBL4101807 ↗
Known as Oxbryta ChEMBL registry synonym — accepted as the source's own label CHEMBL4101807 ↗
Action Inhibit “voxelotor-a first-in-class HbS polymerization inhibitor” PMID 35451176 ↗ Apr 2022
Modality Small molecule “synthetic small molecule supplied as 500 mg tablets” NCT04247594 ↗
Route Oral “GBT440 capsules followed by single dose of \[C14\] GBT440 oral suspension” NCT02497924 ↗